PMA
P980031: INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
FDA PMA · Implant, corneal, refractive · Addition Technology
Key facts
| PMA number | P980031 |
|---|---|
| Trade name | INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS |
| Generic name | Implant, corneal, refractive |
| Applicant | Addition Technology |
| Owner/operator | Addition Technology |
| Product code | LQE |
| Approval date | Apr 9, 1999 |
| Docket number | 99M-1167 |
| Establishment registration | 2953726 |
| FEI number | 3000309468 |
At a glance
- 10–99 Supplements
- May 2, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: